Japan files criminal complaint against Novartis

10 Jan 2014, BioSpectrum Bureau , BioSpectrum

Singapore: Japan's health ministry has lodged a criminal complaint against the local wing of the leading Swiss drug maker Novartis over alleged exaggerated advertising for a popular blood-pressure drug.

The company made the announcement of this complaint in a statement on its website. The statement explained, "Today a criminal complaint was filed by the health, labour and welfare ministry against us over doctor-led clinical research on Diovan for alleged exaggerated advertising banned under the pharmaceutical law."

The ministry is said to have lodged this complaint against Novartis Pharma KK following months of scandal after a university said the data in clinical studies might have been skewed to promote blood-pressure drug Diovan, which is also known as Valsartan.

The company's statement added, "We apologize deeply for causing tremendous worries and trouble to patients, their families, medical workers and the public. We take this incident extremely gravely and will continue to cooperate fully with the authorities."

The incident that stirred up controversy late last year had an employee of the world's second largest drug making company hiding his affiliation during a medical study into the effects of the drug. Reports further revealed that the resulting studies suggested the drug, which is licensed for use in more than 100 countries, had some additional preventative effect on strokes and angina. The firm used data from the studies to market its drug, playing up its supposed additional benefits.

There is no suggestion that Diovan is ineffective in combating blood pressure problems.

Japan's pharmaceutical laws put that anyone found guilty of exaggerated advertising can be punished with up to two years in prison or a fine of as much as $19,400 (two million yen).

The ministry had concluded in September that Novartis Pharma KK should be held responsible for studies at various universities that used manipulated data on the drug.

Mr David Epstein, chief of Novartis Pharmaceuticals apologized for the concern the incident caused, but did not say that the company played any role in the allegations.